Christine Norman-Tiner is Senior Vice President of Regulatory Consulting, bringing more than 25 years of leadership experience across clinical and drug development with specialized expertise in cell and gene therapy and rare disease. She has supported global biopharma organizations, medical device innovators, and academic institutions in navigating complex regulatory pathways, helping shape development strategies from early discovery through late-stage approvals.
Christine is a recognized expert in FDA and global health authority engagement, with deep experience leading programs across a wide range of regulatory submissions and accelerated pathways, including INTERACT, IND, NDA, BLA, IDE, PMA, and expedited designations such as RMAT, Breakthrough Therapy, Orphan Drug, and PRIME. Her cross-functional background spans clinical operations, CMC, quality, and scientific and medical writing, allowing her to align regulatory strategy with both scientific rigor and operational execution.
Known for her collaborative leadership style and ability to guide teams through high-stakes development environments, Christine builds trusted partnerships, mentors regulatory talent, and delivers strategic regulatory support that helps organizations advance programs with confidence and clarity.




